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An Observational Study on MabThera/Rituxan (Rituximab) in Patients With Chronic Lymphocytic Leukemia

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01178086
First received: August 6, 2010
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This observational study will assess the therapeutic efficiency, the treatment schedules and handling procedures, and the safety profile of MabThera/Rituxan (rituximab) in routine care in patients with chronic lymphocytic leukemia. Data from patients will be collected for a total of 24 months.


Condition
Lymphocytic Leukemia, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study on Rituximab in the Therapy of Chronic Lymphocytic Leukemia (CLL NIS)

Resource links provided by NLM:

Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Therapeutic efficiency: Rate of progression-free survival after 2 years in daily routine in patients with chronic lymphocytic leukemia on MabThera/Rituxan therapy [ Time Frame: 72 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ratio of disease progression to death of any cause within the composite endpoint progression-free survival [ Time Frame: 72 months ] [ Designated as safety issue: No ]
  • Dosage/treatment schedule in routine clinical practice [ Time Frame: 72 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse vents [ Time Frame: 72 months ] [ Designated as safety issue: No ]
  • Progression-free survival: Comorbid versus unselected patient cohort [ Time Frame: 72 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events comorbid versus unselected patient cohort [ Time Frame: 72 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: February 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with chronic lymphocytic leukemia on chemotherapy receiving MabThera/Rituxan

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic lymphocytic leukemia requiring treatment
  • Patients receive a chemotherapy in combination with MabThera/Rituxan (decision taken by doctor prior to and independent from inclusion in this non-interventional study)
  • Comorbidities according to CIRS score >6 and/or creatinine clearance <70 ml/min

Exclusion Criteria:

  • Unable or unwilling to give informed consent
  • Contraindication to MabThera/Rituxan
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178086

Contacts
Contact: Please reference Study ID Number: ML22610 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Germany
Recruiting
Frechen, Germany, 50226
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01178086     History of Changes
Other Study ID Numbers: ML22610
Study First Received: August 6, 2010
Last Updated: May 7, 2013
Health Authority: Germany: Paul-Ehrlich Institute

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Disease Attributes
Pathologic Processes
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013